HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS
FDA premarket approval P840029/S005 · decided 1993-05-11
Approval details
- PMA number
- P840029
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS
- Generic name
- PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
- Applicant
- Maquet Cardiovascular, LLC
- Date received
- 1991-04-19
- Decision date
- 1993-05-11
- Days to decision
- 753 days
- Decision code
- APPR
- Product code
- DSY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Wayne, NJ
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